Paramol tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Paracetamol; Dihydrocodeine tartrate

Available from:

Reckitt Benckiser Healthcare (UK) Ltd

ATC code:

N02AJ01

INN (International Name):

Paracetamol; Dihydrocodeine tartrate

Dosage:

500mg ; 7.46mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

Schedule 5 (CD Inv)

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04070100; GTIN: 5038483000052 5038483000076 5038483000090

Patient Information leaflet

CUSTOMER INFO
Minimum Point Size =9.00pt
TABLETS
Paracetamol 500mg and Dihydrocodeine Tartarate 7.46mg
• This medicine can only be used for the short term treatment
of acute moderate pain when other pain killers have not
worked.
• You should only take this product for a maximum of three
days at a time. If you need to take it for
longer than three days you should see your doctor or
pharmacist for advice.
• This medicine contains dihydrocodeine which can cause
addiction if you take it continuously for more
than three days. This can give you withdrawal symptoms
from the medicine when you stop taking it.
• If you take this medicine for headaches for more than three
days it can make them worse.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.
Always take this medicine exactly as described in this leaflet or
as your doctor or pharmacist have told you.
-
Keep this leaflet. You may need to read it again.
-
Ask your pharmacist if you need more information or advice.
-
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects not listed
in this leaflet. See section 4.
-
You must talk to a doctor if you do not feel better or if you
feel worse after 3 days.
WHAT IS IN THIS LEAFLET
1. What Paramol is and what it is used for
2. What you need to know before you take Paramol
3. How to take Paramol
4. Possible side effects
5. How to store Paramol
6. Contents of the pack and other information
1. WHAT PARAMOL IS AND WHAT IT IS USED FOR
Paramol tablets contain the active ingredients paracetamol
and dihydrocodeine. They are used for the short term
treatment of acute moderate pain which is not relieved by
paracetamol, ibuprofen and aspirin alone such as headache,
migraine, period pain, toothache and other dental pain,
backache, muscular and joint aches and pains and neuralgia.
Paramol Tablets are used for the short term treatment of
acute moderate pain which is not relieved by paracetamol,
ibuprofen and aspi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Paramol Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Paracetamol 500mg
Dihydrocodeine Tartrate 7.46mg
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For the short term treatment of acute moderate pain which is not
relieved by
paracetamol, ibuprofen or aspirin alone and as an antipyretic in
conditions
such as: headache; migraine period pain; toothache and other dental
pain; back
pain; muscular and joint pains and neuralgia.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The lowest effective dose should be used for the shortest duration
necessary to
relieve symptoms.
POSOLOGY
Adults:
One or two tablets every four to six hours.
Do not exceed 8 tablets in any 24 hour period.
Do not take for more than 3 days continuously without medical review.
PAEDIATRIC POPULATION
Adolescents 16 years old and over:
One or two tablets every four to six hours.
Do not exceed 8 tablets in any 24 hour period.
Do not take for more than 3 days continuously without medical review.
Adolescents 12–15 years old:
One tablet every four to six hours.
Do not exceed 4 tablets in any 24 hour period.
Do not take for more than 3 days continuously without medical review.
Children under 12 years:
The product should not be used in children below the age of 12 years
because of the
risk of opioid toxicity due to the variable and unpredictable
metabolism of codeine to
morphine (see section 4.4).
SPECIAL POPULATIONS
HEPATIC
IMPAIRMENT:
Patients
with
hepatic
impairment
should
seek
the
advice of a doctor before taking this product (see section 4.4).
Dosage should
be reduced in chronic hepatic disease.
RENAL IMPAIRMENT: Patients with renal impairment should seek the
advice of
a doctor before taking this product (see section 4.4).
ELDERLY POPULATION: Caution should be exercised with use of the
product in
the elderly (see section 4.4). A healthcare professional should be
consulted to
determine if a dosage reductio